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Volume 82
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10.3797/scipharm.1310-21
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Article

Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques

by
Veera Raghava Raju THUMMALA
1,*,
Mrutyunjaya Rao IVATURI
2 and
Someswara Rao NITTALA
2
1
Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
2
School of Chemistry, Andhra University, Visakhapatnam-530003, A.P., India
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2014, 82(2), 247-264; https://doi.org/10.3797/scipharm.1310-21
Submission received: 24 October 2013 / Accepted: 12 January 2014 / Published: 12 January 2014
Versions Notes

Abstract

This study details the isolation, identification, and characterization of ambroxol’s unknown impurity. One unknown impurity of ambroxol was formed in the formulated drug under stress conditions [40°C /75% relative humidity (RH) for 6 months] with the relative retention time (RRT) 0.68 in RP-HPLC. The impurity was enriched by exposing it to heat and it was isolated by using preparative HPLC. The enriched impurity was purified and characterized using the following sophisticated techniques: 2D NMR (gDQ-COSY, gHSQC, and gHMBC), FTIR, and LC-MS/MS. On the basis of the spectral data, the impurity was characterized as trans-4-(6,8-dibromoquinazolin-3(4H)-yl)cyclohexanol.
Keywords: Ambroxol; RP-HPLC; Unknown impurity; NMR; LC-MS/MS Ambroxol; RP-HPLC; Unknown impurity; NMR; LC-MS/MS

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MDPI and ACS Style

THUMMALA, V.R.R.; IVATURI, M.R.; NITTALA, S.R. Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques. Sci. Pharm. 2014, 82, 247-264. https://doi.org/10.3797/scipharm.1310-21

AMA Style

THUMMALA VRR, IVATURI MR, NITTALA SR. Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques. Scientia Pharmaceutica. 2014; 82(2):247-264. https://doi.org/10.3797/scipharm.1310-21

Chicago/Turabian Style

THUMMALA, Veera Raghava Raju, Mrutyunjaya Rao IVATURI, and Someswara Rao NITTALA. 2014. "Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques" Scientia Pharmaceutica 82, no. 2: 247-264. https://doi.org/10.3797/scipharm.1310-21

APA Style

THUMMALA, V. R. R., IVATURI, M. R., & NITTALA, S. R. (2014). Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques. Scientia Pharmaceutica, 82(2), 247-264. https://doi.org/10.3797/scipharm.1310-21

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